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Normally, research projects need the approval of the Regional Committees for Medical and Health Research Ethics (REC) and the Norwegian Centre for Research Data (NSD).
The first question it is important to ask is whether you are going to use anonymised data or not. Anonymised data are information that cannot be used to identify individuals in the data material, neither directly through names, personal ID numbers or other unique characteristics or indirectly via background variables, nor through a list of names / connection key or encryption formula or code. You must be aware of the fact that the information in itself may be enough to identify the individual participant. The personal data will in such case not be deemed to be adequately anonymised.
You must also note that a compilation of various databases can de-anonymise personal data in such a way that the research participants can be identified.
If the data is totally anonymised, you do not have to apply to an external body.
You can read about how you can conduct projects without registering personal data on NSD's website.
Informasjon and brochure on NSD`s website (in Norwegian only).
There can be cases of doubt in which it is uncertain whether research data has been adequately anonymised or not, e.g. in the case of small samples, in, for example, research on a diagnosis that few people in Norway have or a research project with few research participants within a limited geographical area. In cases of doubt you should check with the data protection official (NSD). NSD also has an informal obligation to notify test that you can try.
If you are going to use data that have not been adequately anonymised in your research project, you must consider what external bodies you must apply for approval from. The objective of the research and the type of data to be used in the research project is decisive for your choice.
Research with an objective other than to generate new knowledge about illness and health can be covered by both the Personal Data Act and the Personal Health Data Filing System Act.
Collection of health informastion for the purpose of obtaining new knowledge about health and illness shall be notified to NSD after REC has made justification assessment.
More information how to notify NSD.
List of definitions of the terms in the table.
More information how to apply to REC.
|Type of project||Approval authority||Legislation||Advisory body|
|Medical and health research||REC||The Health Research Act § 2 (1)||REC|
|Research on human subjects||REC||The Health Research Act § 2 (1)||REC|
|Natural health remedies or other substances consumed by people||REC, State Medicine Agency||The Health Research Act § 2 (3) and the Medicines Act § 3 with Regulations||State Medicines Agency|
|Research in which medical equipment is used on people||REC, Directorate of Health||The Health Research Act § 2 (3)and the Medical equipment Act with Regulations||Directorate of Health|
|Research on human biological material||REC||The Health Research Act § 2 (1) and 4 b)||REC|
|Research that entails collecting health data||REC||The Health Research Act § 2 (1) and 4 d),|
and the Healthcare Act § 21
Procedures for notification to NSD is located on web group for research advisors at faculty/center.